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FDA 510(k)

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E

K-Number: K241358 · 2024-06-13

ApplicantSun Pharmaceutical Industries, Inc.
Decision Date2024-06-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E is a medical device manufactured by Sun Pharmaceutical Industries, Inc.. It received FDA 510(k) clearance on 2024-06-13 under approval number K241358. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E?

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E is a medical device that received FDA 510(k) clearance on 2024-06-13. It is manufactured by Sun Pharmaceutical Industries, Inc.. The 510(k) number is K241358.

When was BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E approved by the FDA?

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E received FDA 510(k) clearance on 2024-06-13, under approval number K241358.

What company makes BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E?

BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E is manufactured by Sun Pharmaceutical Industries, Inc..

What is the FDA product code for BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E?

The FDA product code for BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Related PubMed Literature

PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025) PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025)

Other Devices by Sun Pharmaceutical Industries, Inc.

PMA P990019System, laser, photodynamic therapy

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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